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  Devices and methods for detecting analytes in fluid samplesRelated Patent Categories: Chemical Apparatus And Process Disinfecting, Deodorizing, Preserving, Or Sterilizing, Analyzer, Structured Indicator, Or Manipulative Laboratory Device, Structured Visual Or Optical Indicator, Per Se, In Holder Or Container Having Special FormDevices and methods for detecting analytes in fluid samples description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070128070, Devices and methods for detecting analytes in fluid samples. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] The present invention relates to a device and method for detecting the presence or amount of an analyte in a fluid sample. BACKGROUND OF THE INVENTION [0002] The following Background of the Invention is intended to aid the reader in understanding the invention and is not admitted to be prior art. [0003] A variety of sample collection and test devices for clinical or home uses are available and described in the literature. For example, U.S. Pat. No. 5,376,337 discloses a saliva sampling device in which a piece of filter paper is used to collect saliva from a test subject's mouth and transfer the saliva to an indicator. U.S. Pat. No. 5,576,009 and U.S. Pat. No. 5,352,410 each disclose a syringe type fluid sampling device. In these devices, the collected fluid sample cannot be saved for confirmation testing at a later time after the initial result is obtained. [0004] Many of other sample collection and test devices are inefficient in sample extraction from the collection device. Many of these devices are also very complex in their design and manufacture, and require the use of relatively expensive materials. SUMMARY OF THE INVENTION [0005] The present invention provides devices and methods for detecting the presence or amount of an analyte in a liquid sample. In one embodiment the liquid sample is saliva and the analyte is ethanol or a drug of abuse. The device can contain a sample collector and a receiving cup. The sample collector can contain an absorbent material configured so that the sample collector is conveniently placed into the mouth of a test subject. When the absorbent material has been filled with saliva, the sample collector is inserted into the receiving cup of the device, and placed into a locked position (e.g., by screwing the sample collector into the receiving cup). This causes the absorbent material to be compressed and sample to be extracted and moved onto a test element, which detects the presence or amount of the analyte of interest. [0006] Thus, in a first aspect the present invention provides a device for detecting the presence or amount of an analyte in a fluid sample. The device has a sample collector containing a compressible absorbent member for collecting the fluid sample. The device also contains a receiving cup for receiving and holding the sample collector within the receiving cup. The sample collector has a first position and a second, locked position within the receiving cup, the absorbent member being uncompressed in the first position and being compressed and held within the cup in the second, locked position. The sample collector or the receiving cup also contains at least one test element having reagents for detecting the presence or amount of the analyte in the fluid sample. The test element is in fluid communication with the absorbent member when the sample collector is in the second, locked position. [0007] In one embodiment the sample collector contains a test element holder housing the test element. The test element can be in fluid communication with the absorbent member through a passageway in the sample collector connecting the absorbent member and the test element. In one embodiment the absorbent pad is positioned between the passageway and the test element. The sample collector can have circumferential screw threads, and the receiving cup can have circumferential receiving threads. In one embodiment the screw threads and receiving threads are engaged when the sample collector is in the second, locked position. [0008] In one embodiment the receiving cup is sealed from fluid communication with the exterior when the sample collector is in the second, locked position. In another embodiment the sample collector and the receiving cup are joined by a snap fit connection when the sample collector is in the second, locked position. The absorbent member can be a sponge suitable for placing in the mouth of a test subject, and the fluid sample can be saliva. [0009] In one embodiment the sample collector has a flattened handle for manually gripping the sample collector, and the receiving cup contains the test element. The absorbent member can be in fluid communication with the test element through a passageway in the receiving cup when the sample collector is in the second, locked position. [0010] In another aspect the present invention provides a device for detecting the presence or amount of an analyte in a fluid sample. The device contains a sample collector that has screw threads and a compressible absorbent member for collecting the fluid sample. The device also has a receiving cup for receiving and holding the sample collector within the receiving cup, and the receiving cup contains receiving threads. The sample collector has a first position within the receiving cup, and a second, locked position within the receiving cup where the screw threads and receiving threads are engaged. The absorbent member is uncompressed in the first position and is compressed and held within the cup in the second, locked position. The receiving cup is directly connected to a test element holder containing at least one test element, which has reagents for detecting the presence or amount of the analyte in the fluid sample. The test element is in fluid communication with the absorbent member when the sample collector is in the second, locked position. [0011] In another aspect, the present invention provides methods for detecting the presence or amount of an analyte in a fluid sample. The methods involve using a device as disclosed herein. The steps include placing a volume of fluid sample in the absorbent member, inserting the sample collector into the receiving cup and moving the sample collector to the second, locked position, and determining the presence or amount of analyte in the fluid sample. [0012] In one embodiment the fluid sample is saliva, and the saliva is placed in the absorbent member by placing the sample collector into the mouth of a test subject. [0013] The summary of the invention described above is not limiting and other features and advantages of the invention will be apparent from the following detailed description, as well as from the claims. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 is a perspective view of a device of the invention for detecting the presence or amount of an analyte in a fluid sample. [0015] FIG. 2 is an exploded view of a device of the invention. [0016] FIG. 3 is a perspective view of a device of the invention, where the sample collector is in the first position and the sample collector and receiving cup are separated. [0017] FIG. 4 is a perspective view of a device of the invention in the second, locked position. Illustrated is a procedure for extracting sample from a device that has previously been loaded with sample. In this embodiment sample is extracted from the sampling hole using a pipette. [0018] FIG. 5 is a cross-sectional view of a device of the invention in the first position, where the absorbent material (here a sponge) is uncompressed. [0019] FIG. 6 is a cross-sectional view of a device of the invention in the second, locked position, where the absorbent material is compressed. [0020] FIG. 7 is a cross-sectional view of a device of the invention illustrating the sample storage area in the device. Continue reading about Devices and methods for detecting analytes in fluid samples... 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